The Effects Of Music In Retrograde Intrarenal Surgery

Sponsor

Afyonkarahisar Health Sciences University (Other)

Overall Status

Completed

CT.gov ID

NCT04500054

Collaborator

(none)

Enrollment

Location

Arms

7.6

Actual Duration (Months)

7.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aimed to investigate the effect of music listening during the preoperative and postoperative stages in patients undergoing retrograde intrarenal surgery(RIRS) on basic life findings, anxiety, pain, and the amount of analgesic used. This is a randomized controlled experimental study.

The study was conducted with two groups: the intervention group (n=30) and control group (n=30). The control group received standard care. In contrast, the intervention group, in addition to standard care, was listened to the music by the researchers for 15 minutes one hour before their surgery.

Condition or Disease	Intervention/Treatment	Phase
Retrograde Intrarenal Surgery	Other: Music Listening	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

The Effects Of Music Listening In Patients Undergoing Retrograde Intrarenal Surgery On Basic Life Findings, Anxiety, Pain, And The Amount Of Analgesic Used.

Actual Study Start Date :

May 14, 2019

Actual Primary Completion Date :

Dec 31, 2019

Actual Study Completion Date :

Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Music Intervention Group The music intervention group listened to the music by the researchers for the duration of 15 minutes one hour before the surgery as well as the standard care.	Other: Music Listening The music type was chosen by the patients and researchers did not have any influence on their choices.
No Intervention: No Intervention Group The control group patients received standard care only.

Arm

Intervention/Treatment

Experimental: Music Intervention Group

The music intervention group listened to the music by the researchers for the duration of 15 minutes one hour before the surgery as well as the standard care.

Other: Music Listening

The music type was chosen by the patients and researchers did not have any influence on their choices.

No Intervention: No Intervention Group

The control group patients received standard care only.

Outcome Measures

Primary Outcome Measures

Visual Analog Scale for Anxiety (VAS-A) [2 days]
VAS-A is a 10 cm long measuring instrument with the score range from 0 to 10 with 0 points showing "no anxiety" and 10 points showing "I feel a lot of anxiety" .

Secondary Outcome Measures

Visual Analog Scale for Pain (VAS) [1 day]
VAS scale is a single-dimensional scale that is commonly used to evaluate pain severity. According to VAS, pain intensity is rated as "no pain" with 0 points, and "the most severe pain imaginable" with 10 points. Pain intensity ranges were determined by VAS as follows; mild pain below 3 points, as moderate pain between 3 and 6 points, and as severe pain above 6 points.The VAS pain scale was applied to the patients once on the first postoperative day, for the level of pain they felt.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

18 years of age or above,
had elective RIRS,
without hearing/speech impairment,
without mental problems,
without a diagnosis of psychiatric disorders,
without a diagnosis of depression,
had the surgery under general anesthesia,
and volunteered to participate.

Exclusion Criteria:

Patients under 18 years of age,
with hearing/speech impairment,
with mental problems,
with a diagnosis of psychiatric disorders,
with a diagnosis of depression,
undergoing the surgery through spinal anesthesia,
not willing to participate in the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Afyonkarahisar Health Science University	Afyonkarahisar	Centre	Turkey	03200

Sponsors and Collaborators

Afyonkarahisar Health Sciences University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yeliz Ciğerci, Assistant Proffesor PhD, Afyonkarahisar Health Sciences University

ClinicalTrials.gov Identifier:

NCT04500054

Other Study ID Numbers:

(2019/165

First Posted:

Aug 5, 2020

Last Update Posted:

Aug 5, 2020

Last Verified:

Aug 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 5, 2020